(115 days)
No
The description focuses on stereotactic guidance, CT data processing for planning and navigation, and a robotic arm for passive constraint within software-defined boundaries. There is no mention of AI or ML algorithms for tasks like image analysis, decision support, or adaptive control. The "intelligent" tool holder description appears to refer to its ability to follow software-defined constraints, not AI-driven intelligence.
No.
The "Intended Use" states that the device is intended to assist the surgeon "in providing software defined spatial boundaries for orientation and reference information to anatomical structures" and to assist the physician with "presurgical planning and interpretive navigation." The device primarily serves as a "tool guide" for precision during orthopedic procedures, rather than directly treating or diagnosing a disease or condition. Its function is to facilitate the surgeon's efforts in preparing the site for an implant.
No
The device is described as assisting in surgical guidance and preparation for orthopedic implants, not in diagnosing conditions or diseases.
No
The device description explicitly states that the TGS includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and the TGS robotic arm, which is an electromechanical arm. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Tactile Guidance System is a surgical navigation and guidance system used during orthopedic procedures. It assists the surgeon with spatial orientation and reference information based on pre-operative CT data. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's for assisting the surgeon during surgical knee procedures.
- Device Description: The description details a stereotaxic instrument with an optical detector, computer, robotic arm, etc., all used for surgical guidance, not for analyzing biological samples.
Therefore, the Tactile Guidance System falls under the category of a surgical guidance or navigation system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Tactile Guidance System is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:
- . Unicondylar knee replacement
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The TGS is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and the TGS robotic arm. TGS uses patient CT data to assist the physician with presurgical planning and interpretive navigation. The TGS robotic arm, which is an add-on to the Navigation Module, serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS robotic arm, an electromechanical arm, is passively constrained by softwaredefined spatial boundaries implemented through the use of the TGS robotic arm and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as drills, awls, and 3rd party drill systems.
Summary of Technological Characteristics: The TGS consists of the following basic components:
- High Resolution Color Liquid Crystal Display (LCD) Touch Screen Monitor
- Second High Resolution LCD screen that shows an identical image to the primary touch screen.
- Uninterruptible Power Supply (UPS)
- Central Processing Unit (CPU)
- Isolation Transformer
- Keyboard and Mouse
- Optical Detector
- Operating Room (OR) Cart
- Foot control panel
- Tool and accessories optically tracked surgical tools and accessories
- TGS robotic arm tool platform that is connected to the Voyager Navigation Platform to enable passive stereotactic guidance of any cleared standard surgical tool such as 30 party drill systems (e.g., Anspach's eMax (K011444)) to prepare anatomical sites for placement of orthopedic implants in a minimally invasive manner.
- Voyager software application
- Linux operating system
- Software drivers for video grabber, standard components (keyboard, mouse, monitor, etc.)
- Preoperative planning laptop that runs only the preoperative planning portion of the application. Dicom CDs of CT scans with patient data can be loaded and surgical plans can be created on this laptop and downloaded (in an encrypted format) to a USB memory stick to be transferred to the TGS.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT data, Dicom CDs of CT scans
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Operating Room (OR)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K052851, K062146, K031454, K031337, K041899, K071714
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
Ko72806
Image /page/0/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters underneath. Above the word "MAKO" is a stylized graphic that resembles a shark fin or a mountain peak. The logo is simple and modern, and the use of bold letters and a strong graphic gives it a sense of power and authority.
Page 1 of 2
JAN 24 2006
lori lauderdale, fronda 33317 ....... 2595 dare road 184 954 327 2044 36 1454 827 0426
ATTACHMENT 1 510(K) SUMMARY
| Submitter: | |
|---|---|
| Address: | |
| Phone number: | |
| Fax number: | |
| Contact Person: | |
| Date Prepared: | |
| Device Trade Name: | |
| Common Name: | |
| Classification Name: | |
| Classification #: |
MAKO Surgical Corp. 2555 Davie Road, Fort Lauderdale, FL, 33317 954-927-2044 x. 605 954-927-0446 William F. Tapia September 28 2007 Tactile Guidance System (TGS) Stereotaxic Instrument Class II 21 CFR 882 4560
Substantial Equivalence Claimed To: The TGS is substantially equivalent to the Voyager / Tactile Guidance System - CT (K052851), Uni-Knee Surgetics Navigation System (K062146), Acumen System (K031454, K031337), Vectorvision Uni-Knee (K041899), and Navitrack System-OS Unicondylar Knee Universal (K071714).
Description: The TGS is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and the TGS robotic arm. TGS uses patient CT data to assist the physician with presurgical planning and interpretive navigation. The TGS robotic arm, which is an add-on to the Navigation Module, serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS robotic arm, an electromechanical arm, is passively constrained by softwaredefined spatial boundaries implemented through the use of the TGS robotic arm and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as drills, awls, and 3rd party drill systems.
Summary of Technological Characteristics: The TGS consists of the following basic components:
- High Resolution Color Liquid Crystal Display (LCD) Touch Screen Monitor ﮩ
- Second High Resolution LCD screen that shows an identical image to the primary touch screen.
- Uninterruptible Power Supply (UPS)
- Central Processing Unit (CPU) ব
-
- Isolation Transformer
- ్. Keyboard and Mouse
-
- Optical Detector
- Operating Room (OR) Cart 8.
- Foot control panel ഗ്
-
- Tool and accessories optically tracked surgical tools and accessories
-
- TGS robotic arm tool platform that is connected to the Voyager Navigation Platform to enable passive stereotactic guidance of any cleared standard surgical tool such as 30 party drill systems (e.g., Anspach's eMax (K011444)) to prepare anatomical sites for placement of orthopedic implants in a minimally invasive manner.
-
- Voyager software application
-
- Linux operating system
-
- Software drivers for video grabber, standard components (keyboard, mouse, monitor, etc.)
-
- Preoperative planning laptop that runs only the preoperative planning portion of the application. Dicom CDs of CT scans with patient data can be loaded and surgical plans can be created on this laptop and downloaded (in an encrypted format) to a USB memory stick to be transferred to the TGS.
1
Image /page/1/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters underneath. Above the word "MAKO" is a stylized graphic that resembles a mountain range or a wave. The number 6072806 is written in the upper left corner of the image.
Page 2 of 2
2555 davie isad............................................................................................................................................................... ..............................................................................................................................................................................
Intended Use/Indications for Use: The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Tactile Guidance System is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:
- . Unicondylar knee replacement
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2008
Mako Surgical Corporation % Mr. William F. Tapia Vice President, RA/QA 2555 Davie Road Ft. Lauderdale, Florida 33317
Re: K072806
Trade/Device Name: Tactile Guidance System (TGS) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 16, 2008 Received: January 17, 2008
Dear Mr. Tapia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. William F. Tapia
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Mulhusan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters underneath. Above the word "MAKO" is a stylized mountain peak. The logo is black and white.
2555 davie road fort louderdale, florida 33317 tel 954 927 2044 fax 954 927 0446
ATTACHMENT 2
INDICATIONS FOR USE
510(k) Number (if known): K072806
Device Name: Tactile Guidance System (TGS)
Indications for Use:
The Tactile Guidance System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Tactile Guidance System is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:
Unicondylar knee replacement .
Prescription Use _ X
OR
Over-the-Counter Use_
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Minh M. Millkuss
Division of Gen and Neus
510(k) REVIEW